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The Impact of Left Stellate Ganglion Block on Systemic Inflammation and Neuromodulation in CABG Surgery.

ConditionsDelirium - PostoperativeInflammation BiomarkersStellate Ganglion BlockCABG
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorOMAR ABDELAZIZ ABOELFADL

About this trial

((82)) patients scheduled to undergo elective CABG by the same surgical team will be allocated randomly by computer-generated random numbers into two equal groups (n= 41).

Study groups:

Group S (Stellate Ganglion Block Group):

Patients will receive an ultrasound-guided Left stellate ganglion block prior to induction of general anesthesia. The block will be performed at the C6 level under strict aseptic precautions using 5 mL of 0.25% bupivacaine. Successful blockade will be confirmed by the appearance of ipsilateral Horner's syndrome.

Group C (Control Group):

Patients will receive standard perioperative care without stellate ganglion block and will undergo the same anesthetic and surgical management protocol as Group S.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All elderly (≥65 years) patients of both genders, as according to the World Health Organization, the chronologic age of 65 years was accepted by most developed countries in the world as a definition of "elderly" or older person. Patients scheduled for elective cardiac surgery under general anesthesia.14

American Society of Anesthesiologists (ASA) physical status class II or III.

Patients will be stratified according to their baseline surgical risk utilizing the EuroSCORE II tool >4%15.

American Society of Anesthesiologists (ASA) physical status class II or III.

Disqualifiers

Pre-existing dementia or significant cognitive impairment.

History of stroke or cerebrovascular disease.

Contraindications to SGB (e.g., coagulopathy, local infection, or anatomical abnormalities).

Preoperative use of antipsychotics or antidepressants.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stellate Ganglion Block

    Procedure/Surgery

    ultrasound guided left stellate ganglion block in patients undergoing CABG surgery to compare with control group which not receive any block even SHAM block and show its effect on reducing inflammatory biomarkers especially il6 and its effect in reducing postoperative delirium

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: stellate ganglion blockExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Interleukin 6 (IL-6) level in pg/ml change from baseline

Time frame
0 (baseline) and 6 hours after cardiopulmonary bypass

Secondary outcomes

1

1. Incidence of postoperative delirium

A trained nurse will evaluate the patients two times (06:00-08:00 and 18:00-20:00). The confusion assessment method CAM-ICU. This method includes the following four evaluation indicators: (1) changes in mental state or fluctuations in consciousness levels during acute attacks; (2) lack of concentration; (3) confused thinking and (4) changes in level of consciousness. If both features 1 and 2 are positive and at least one of the features 3 or 4 is positive, the diagnosis is delirium. Subtypes of delirium are classified according to RASS score: hyperactive type (RASS \>0), hypoactive type (RASS\<0), and mixed type (alternating between hypoactive and hyperactive types).

Time frame
day 0 to 3 days after successful extubation
2

2. Delirium severity will be assessed using the Delirium Rating Scale-Revised-98.

This scale features 16 items rated by clinicians and is divided into two sections: one with 13 severity items and another with three diagnostic items. Each severity item is scored from 0 to 3 points, while the diagnostic items are rated from 0 to 2 or 3 points.

Time frame
day 0 to 3 days after successful extubation
3

3. CRP in mg/L, neutrophil to lymphocyte ratio (NLR) and Platelet to white cell ratio (PWR).

Time frame
day 0 (baseline) to day 3
4

4. Creatinine baseline level in mg/dl, 24 h postoperatively, 48 h postoperatively, and the urine output was recorded on the first and second postoperative days.

Time frame
0 (baseline) to 48 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OMAR ABDELAZIZ ABOELFADL

Lead sponsor

Assiut University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: